Do you think designating Wegovy and Mounjaro as "medicines of concern for misuse and abuse" can prevent the misuse and abuse of obesity treatments?
It emerged on the 2nd that the Ministery of Food and Drug Safety is proceeding with procedures to designate obesity treatments such as Wegovy and Mounjaro as "medicines of concern for misuse and abuse." After regulatory review and an administrative notice, the related notice is expected to be revised as early as this month.
If designated as a medicine of concern for misuse and abuse, a related warning phrase must be displayed on the product packaging, and the drug cannot be sold without a doctor's prescription even in areas exempt from the separation of prescribing and dispensing (eup, myeon, and island areas where it is difficult to use medical institutions and pharmacies together). It will also be subject to monitoring of prescription status through the Drug Utilization Review (DUR) of the Health Insurance Review & Assessment Service (HIRA).
The government cites the growing use for cosmetic purposes amid a weight-loss craze and the rise in illegal online transactions, overseas direct purchases, and shopping trips abroad as the background for pushing the regulation.
On the other hand, some in the medical community and industry argue that the regulation is inappropriate and has limits in effectiveness.
As the market rapidly expands with the advent of obesity treatments that mimic the action of glucagon-like peptide (GLP)-1, a hormone secreted in the gut, debate continues over whether designating them as medicines of concern for misuse and abuse is an appropriate solution.
◇ "Unbridled use must be prevented"… Government to tighten control on misuse and abuse
Wegovy by Novo Nordisk and Mounjaro by Eli Lilly and Company were launched in the domestic market in Oct. 2024 and Aug. 2025, respectively. They gained sensational popularity, to the point that shortages appeared in the domestic market.
The problem is that controversy erupted as prescriptions increased not only for patients with obesity but also for consumers of normal weight or merely overweight for cosmetic purposes.
The Ministery of Food and Drug Safety believes that designating them as medicines of concern for misuse and abuse is a minimum safety device to manage these problems.
In fact, social media and online communities are flooded with weight-loss reviews and prescription information using obesity treatments. So-called "shopping trips" to buy products overseas, including in Japan, are also increasing. Some local pharmacies tout low prices and are even called "holy places for obesity treatments."
The Ministery of Food and Drug Safety warns that, in the case of medicines distributed overseas, it is difficult to verify manufacturing and distribution channels and the possibility that counterfeit medicines are mixed in cannot be ruled out. A recent inspection of the distribution status of GLP-1 class obesity treatments found pharmacies that sold medicines without a prescription or failed to prepare medical records.
The industry expects the Ministery of Food and Drug Safety to use the designation as medicines of concern for misuse and abuse as a basis to strengthen monitoring of advertising and sales activities, and to promote more systematic crackdowns in cooperation with related agencies such as the Korea Customs Service.
◇ "The paradox of regulating only treatments"
However, rebuttals to this measure are mounting in the medical field. Critics say the measure lacks effectiveness and could reinforce social stigma against obesity.
A pharmacovigilance expert formerly with a global big pharma said, "GLP-1 class obesity treatments have no clinically identified patterns of abuse or addictive profiles," and noted, "They are not classified as drugs with abuse risk in the United States or Europe."
It is difficult to find cases where regulators in the United States, Europe, or Japan operate a separate management system like Korea's "medicines of concern for misuse and abuse," and the general approach is to focus crackdowns only on counterfeit medicines, illegal online sales, and the distribution of unapproved products.
A clinic physician said, "Only recently has there been a trend to recognize obesity as a disease, and attaching the expression 'concern for misuse and abuse' to obesity treatments itself can reinforce social stigma about treatment."
The physician said, "Wegovy and Mounjaro are not simple weight-loss drugs but treatments that help with blood sugar control, reduced cardiovascular risk, and improved metabolic diseases in patients with obesity," and argued, "If anything, by introducing reimbursement and clarifying indications and prescribing criteria, problems of misuse and abuse arising in the non-reimbursed market can be eased."
Some also say that attaching warning phrases to domestic product packaging will not solve the problems of overseas direct purchases and shopping trips abroad. They argue that it is a matter of demand structure, and it is not appropriate to regulate the treatments.